Multiple SclerosisNCT02236624
Aerobic Exercise and Flu-like Symptoms Following Interferon Beta 1a Injections in Patients With Multiple Sclerosis?
A study testing Aerobic exercise in people with Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of the present study is to test the hypothesis that aerobic training can reduce flu-like symptoms following interferon beta 1a injections in patients with Multiple Sclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Definite relapsing-remitting MS according to the McDonald criteria
- Treated with IFNß-1a (Avonex®) for at least 6 months
- Frequent experiencing FLS (muscle aches, chills, fatigue, fewer9) in the hours following IFNß-1a injection (self-reporting that this happens 75% or more of the times after injection).
- Female subjects of childbearing potential are required to practice effective contraception during the study and to continue contraception for 30 days after their last dose of study treatment.
- Expected to be able to complete the aerobic exercise intervention
- Willingly to transport themselves to the exercise/testing facility
- Give informed consent
- Age above 18 years
Who cannot join
- Have FLS (i.e. muscle aches, chills, fatigue or fewer) or serious infection within a 24h period prior to the screening. Patients having chronic FLS or infection will, therefore, be excluded. This will be tested by patient interview and, if required, further examination
- Have a known history or positive test result for hepatitis B, hepatitis C, or HIV
- Use beta-blockers.
- Have clinically significant abnormality in laboratory or electrocardiogram measures, chronic fatigue syndrome or fibromyalgia, pre-malignant disease, or malignant disease
- Have had allergy shot or desensitization therapy within 1 month of day 1 (randomization) vaccination within 2 weeks of day 1.
- Stop taking IFNß-1a.
- Are pregnant.
- Suffer from dementia, alcohol abuse or have a pacemaker.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Sport Science, Department of Public Health, Aarhus University
Aarhus, Aarhus C, 8000
About this study
Official title: Can Aerobic Exercise Reduce Flu-like Symptoms Following Interferon Beta 1a Injections in Patients With Multiple Sclerosis?
The purpose of the present study is to test the hypothesis that aerobic training can reduce flu-like symptoms following interferon beta 1a injections in patients with Multiple Sclerosis.
A secondary purpose is to evaluate whether or not changes in circulating cytokines provide a mechanism that can explain a potential positive effect.
Read the detailed description
Flu-like symptoms (FLS) such as fever, muscle aches, chills, and fatigue are common side effects of interferon beta (IFN-ß) treatment and may affect the willingness of patients with multiple sclerosis (MS) to initiate therapy. The initiation phase of MS treatment is a critical period that can affect patients' views on the long-term acceptability and the adherence to the therapy, underscoring the need for strategies to reduce treatment-related adverse events such as FLS following IFN-ß injections.
Once-weekly intramuscular IFNß-1a, which has been available since 1996, is indicated for the treatment of patients with relapsing forms of MS to slow the accumulation of physical disability progression and the frequency of clinical exacerbations. Although intramuscular IFNß-1a is generally well tolerated, FLS have been reported in up to 76% of patients receiving this treatment. Consequently, interventions that can reduce FLS after IFNß-1a injection are warranted. One approach to reduce FLS has been dose titration. Titration is the practice of initiating therapy with a lower starting dose and gradually increasing the dose at defined intervals until the full dose is reached. Moreover, a combination of dose titration and pre-treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen in healthy subjects, has been sown to reduce FLS severity by 37-76%. However, not all patients benefit from dose titration and also the effects in MS still have to be determined. Consequently, other types of FLS management after IFNß-1a injection have to be determined.
Interestingly, case reports from both Finland and Denmark suggest that aerobic exercise is able to markedly reduce FLS symptoms in MS patients, but so far no studies have evaluated this. However, from healthy subjects it is known that aerobic exercise is capable of positively influencing the immune system and evidence suggests that the prophylactic effect of exercise may, to some extent, be the induction of an anti-inflammatory environment with each bout of exercise (e.g. via increases in circulating anti-inflammatory cytokines including interleukin (IL)-1 receptor antagonist and IL-10).
The existing evidence is particularly suggestive of an acute effect of aerobic exercise on the circulating cytokine levels, which could be an important mechanism in explaining a potential positive effect of aerobic exercise on FLS.
Consequently, the purpose of the present study is to test the hypothesis that aerobic training can reduce FLS following interferon beta 1a injections in patients with Multiple Sclerosis.
A secondary purpose is to evaluate whether or not changes in circulating cytokines provide a mechanism that can explain a potential positive effect.
- Conditions
- Multiple Sclerosis
- Being tested
- Aerobic exercise
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | Not described Receives: Behavioral: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flu-like symptoms assessment
Comparison of the mean relative change in flu-like symptoms severity from pre-injection to 5 hours post-injection. At 12h and 24h post intervention the participants will further register flu-like symptoms.
Measured: Change from baseline to 24 hours.
Secondary outcomes (1)
Bloodbourne biomarkers
Bloodbourne biomarkers: Cytokines
Measured: Baseline to 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, MS-Clinic of Southern Jutland, MS-Clinic Viborg, MS-Clinic Odense, Biogen
- Responsible party
- Sponsor
- Investigators
- Martin Langeskov-Christensen, MSc, Principal investigator, Sport Science, Department of Public Health, Aarhus UniversityUlrik Dalgas, PhD, Study chair, Sport Science, Department of Public Health, Aarhus UniversityEgon Stenager, Dr.med., Study chair, MS-Clinic of Southern Jutland (Sønderborg, Vejle, Esbjerg), Department of Neurology, Sønderborg, Denmark and Institute of Regional Health Services, University of Southern Denmark.Thor Petersen, Dr.med., Study chair, MS-Clinic Aarhus, Department of Neurology, Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236624
- Sponsor's protocol ID
- Avonex
- Status last verified
- Jul 2014
- First submitted
- 8 Sep 2014
- Last updated
- 19 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Aerobic Exercise Reduce Flu-like Symptoms Following Interferon Beta 1a Injections in Patients With Multiple Sclerosis?
- ClinicalTrials.gov ID
- NCT02236624
- Acronym / sponsor ID
- Avonex
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, MS-Clinic of Southern Jutland, MS-Clinic Viborg, MS-Clinic Odense, Biogen
- Study start
- Mar 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present study is to test the hypothesis that aerobic training can reduce flu-like symptoms following interferon beta 1a injections in patients with Multiple Sclerosis.
A secondary purpose is to evaluate whether or not changes in circulating cytokines provide a mechanism that can explain a potential positive effect.
Detailed description
Flu-like symptoms (FLS) such as fever, muscle aches, chills, and fatigue are common side effects of interferon beta (IFN-ß) treatment and may affect the willingness of patients with multiple sclerosis (MS) to initiate therapy. The initiation phase of MS treatment is a critical period that can affect patients' views on the long-term acceptability and the adherence to the therapy, underscoring the need for strategies to reduce treatment-related adverse events such as FLS following IFN-ß injections.
Once-weekly intramuscular IFNß-1a, which has been available since 1996, is indicated for the treatment of patients with relapsing forms of MS to slow the accumulation of physical disability progression and the frequency of clinical exacerbations. Although intramuscular IFNß-1a is generally well tolerated, FLS have been reported in up to 76% of patients receiving this treatment. Consequently, interventions that can reduce FLS after IFNß-1a injection are warranted. One approach to reduce FLS has been dose titration. Titration is the practice of initiating therapy with a lower starting dose and gradually increasing the dose at defined intervals until the full dose is reached. Moreover, a combination of dose titration and pre-treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen in healthy subjects, has been sown to reduce FLS severity by 37-76%. However, not all patients benefit from dose titration and also the effects in MS still have to be determined. Consequently, other types of FLS management after IFNß-1a injection have to be determined.
Interestingly, case reports from both Finland and Denmark suggest that aerobic exercise is able to markedly reduce FLS symptoms in MS patients, but so far no studies have evaluated this. However, from healthy subjects it is known that aerobic exercise is capable of positively influencing the immune system and evidence suggests that the prophylactic effect of exercise may, to some extent, be the induction of an anti-inflammatory environment with each bout of exercise (e.g. via increases in circulating anti-inflammatory cytokines including interleukin (IL)-1 receptor antagonist and IL-10).
The existing evidence is particularly suggestive of an acute effect of aerobic exercise on the circulating cytokine levels, which could be an important mechanism in explaining a potential positive effect of aerobic exercise on FLS.
Consequently, the purpose of the present study is to test the hypothesis that aerobic training can reduce FLS following interferon beta 1a injections in patients with Multiple Sclerosis.
A secondary purpose is to evaluate whether or not changes in circulating cytokines provide a mechanism that can explain a potential positive effect.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Behavioral: Aerobic exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Definite relapsing-remitting MS according to the McDonald criteria
- Treated with IFNß-1a (Avonex®) for at least 6 months
- Frequent experiencing FLS (muscle aches, chills, fatigue, fewer9) in the hours following IFNß-1a injection (self-reporting that this happens 75% or more of the times after injection).
- Female subjects of childbearing potential are required to practice effective contraception during the study and to continue contraception for 30 days after their last dose of study treatment.
- Expected to be able to complete the aerobic exercise intervention
Key exclusion criteria (8 listed)
- Have FLS (i.e. muscle aches, chills, fatigue or fewer) or serious infection within a 24h period prior to the screening. Patients having chronic FLS or infection will, therefore, be excluded. This will be tested by patient interview and, if required, further examination
- Have a known history or positive test result for hepatitis B, hepatitis C, or HIV
- Use beta-blockers.
- Have clinically significant abnormality in laboratory or electrocardiogram measures, chronic fatigue syndrome or fibromyalgia, pre-malignant disease, or malignant disease
- Have had allergy shot or desensitization therapy within 1 month of day 1 (randomization) vaccination within 2 weeks of day 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise | Behavioural | Aerobic Exercise |
Primary outcome
Flu-like symptoms assessment
Time frame: Change from baseline to 24 hours.
Comparison of the mean relative change in flu-like symptoms severity from pre-injection to 5 hours post-injection. At 12h and 24h post intervention the participants will further register flu-like symptoms.
1 secondary outcome
Bloodbourne biomarkers
Time frame: Baseline to 24h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Langeskov-Christensen, MSc principal investigator
Sport Science, Department of Public Health, Aarhus University
Ulrik Dalgas, PhD study chair
Sport Science, Department of Public Health, Aarhus University
Egon Stenager, Dr.med. study chair
MS-Clinic of Southern Jutland (Sønderborg, Vejle, Esbjerg), Department of Neurology, Sønderborg, Denmark and Institute of Regional Health Services, University of Southern Denmark.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flu-like symptoms assessment (time frame: Change from baseline to 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.